About | RegenoCELL Therapeutics, Inc. - Adult Stem Cell Therapy for Congestive Heart Failure

About RegenoCELL

The mission of RegenoCELL Therapeutics, Inc. (OTC BB: RCLL) is to bring stem cell therapy treatments to the market as quickly as possible. Stem cells have the ability to produce other cells identical to themselves or to differentiate into specific cell lineages which can be used in the regeneration and repair of damaged tissue. RCLL is utilizing adult stem cells, those derived from the patient’s own blood, which eliminates the ethical and safety concerns associated with embryonic and umbilical cord blood stem cells.

RCLL’s therapy utilizes a process to identify adult stem cells found in a patient’s blood. In circulating blood, the numbers of adult stem cells present are less than 1% of 1% of all the cells found in the blood. At the Company’s manufacturing operations in Israel, sufficient stem cells are segregated from the half liter of blood drawn from the patient and then rapidly grown from tens of thousands into many millions over a five day period. This occurs in a standard class 10,000 clean room with the handling of the cells under a class 100 hood.

The adult stem cells and other mature cells extracted from the circulating blood have been selected because of their ability to differentiate into angiogenic precursor cells, or blood vessel forming cells. When these angiogenic precursor cells are administered to the patient, they are primed to form new blood vessels.

Currently congestive heart failure patients cleared for treatment have one-half liter of blood drawn which is sent to the Company’s cell processing facility in Israel. After the adult stem cells in the patient’s blood have been extracted and grown into large numbers of angiogenic precursor cells, they are sent to Bangkok, Thailand, the Dominican Republic and other locations where importation of the autologous stem cell therapy product is permitted for infusion into the patient in a minimally invasive procedure. The stem cell therapy product is either delivered through a catheter or injected directly into the myocardium. All patients are private pay.

RCLL’s primary asset is Regenocell Laboratories, Ltd., a wholly owned Israeli corporation, which is manufacturing the stem cell therapy product used to treat congestive heart failure and peripheral artery disease. Marketing of the stem cell therapy product either directly or through distributors is done by Regenocell, Ltd., a wholly owned Antigua and Barbuda corporation.

RCLL’s plan to further build its business is to submit an IND to the Food and Drug Administration and its equivalent to the European Medicines Agency to initiate clinical trials in order to apply and obtain approval for the treatment of peripheral artery disease in the United States and Europe. There are over ten million people suffering from the lack of sufficient blood flow to the extremities in the United States and an equal number in Europe. This disease is most often experienced by diabetics in their toes and lower legs. Pilot studies have demonstrated that there is new blood vessel formation which saves the patient from what would progress to amputation.